Intravitreal injection (IVI) is the most commonly performed intraocular procedure worldwide. Several manufacturers have developed glass prefilled syringe (PFS) devices to increase ease of performing IVIs and reduce complications associated with medication preparation. This formative human factors study assessed a novel, polymer PFS alternative to glass syringes to support development of a usable, silicone-free delivery platform for IVI. Thirteen retina specialists (RSs) with experience preparing a minimum of ?10 IVIs per week completed the study. RSs were presented with the concept device and prototype instructions for use, and completed hands-on tasks to simulate IVI. They then evaluated the concept device for ease of use, comfort, safety, and overall preference versus the IVI devices they are accustomed to using. The primary objectives were to assess the ease of use and acceptability of the proposed syringe design, evaluate the corresponding IFU, and identify any potential usability issues. The secondary obants and may offer an improvement to currently available systems for IVI.To address the challenges related to the interconnectivity between vial container closure systems and vial transfer devices, pharmaceutical, elastomer and transfer device manufacturers have formed a working group under the Product Quality Research Institute (PQRI) to establish best practices for the evaluation of the assembly of vial transfer devices and vial systems. As part of the project, the first activity was to quantify the nature and frequency of issues (complaints). To this end, the working group conducted a survey with questionnaires related to categories and numbers of complaints, regions/countries where complaints were received and nature of the manufacturers who received the complaints. The survey was distributed to the sixteen companies participating in the working group and eleven companies submitted a response. Besides quantifying and ranking the frequency of issues, the survey determined what issues are common across all companies and what issues may be product-specific or specific by manufacturer. In this report, the analysis and outcomes of the survey will be presented, and the next steps will be discussed.This study investigated the gas flow mechanism through microchannels in a flexible single-use packaging system composed of multilayer plastic film. The relationship was studied between the gas flow rate and several parameters, which included the differential pressure as an external parameter and channel geometries as internal parameters. Based on the results of this study, empirical formulas were derived that show the different dependency of the parameters for each gas flow regime. It was found that these formulas are suitable for calculating the size of a leak in a defective product directly from the corresponding flow rate. The test samples used were 50 mm patches of an ethylene vinyl acetate multilayer film (300 μm and 360 μm thick) and a polyethylene multilayer film (400 μm thick). Artificial leaks were laser-drilled in a range of sizes from 2 μm to 100 μm into the center of each patch. The patches were assembled in a filter holder to form a leak-tight seal and were mounted on the test setup. The test setup included the flow measurement device and pressure controller that used compressed air to produce a certain differential pressure. Various differential pressures were applied to each test unit to cover the whole range of desired use-case conditions. To understand and interpret the effect of the physics and geometry of the microchannels on flow rate measurement, the microscopic investigations performed in our previous study were used. All measurements were carried out under laboratory temperature conditions of 20°C.Freeze-drying is the drying technology of choice for sensitive biological drugs. On the one side, it is admired for its suitability for the stabilization of sensitive molecules. On the other side, it is a time-consuming production step posing challenges in process development and technology transfer. The application of controlled ice nucleation is one elegant approach to shorten freeze-drying times significantly and at the same time increasing batch homogeneity. However, a reliable 100% control of the controlled nucleation step in each vial is essential considering the impact of the nucleation temperature on product quality attributes. In this study, we introduce a camera-supported optical inspection method that utilizes the different superficial cake structures seen in controlled and random nucleated lyophilizates. Derived from the grayscale analysis the new distinguishing criterion ″average edge brightness″ is introduced. Four different formulations containing Sucrose, Trehalose, and/or BSA were freeze-dried with random or controlled nucleation and analyzed with the new technology. A proof of concept is provided by the analysis of a similar-to-market lyophilized monoclonal antibody formulation freeze-dried with three different freezing protocols covering different nucleation profiles. For all investigated formulations and process conditions, the clear discrimination of controlled and randomly nucleated vials was possible. By this, the technology allowed for reliable, non-invasive, and automatable 100% monitoring of controlled nucleation success after freeze-drying.In cleanroom facilities, both disposable and reusable textile garments (coveralls, boots, hoods, and frocks) meet the particulate standards from most rigorous to the most basic levels. https://www.selleckchem.com/products/pf-04965842.html However, the reusables clearly offer two other important benefits, lower annual cost and lower environmental impact. The objectives of this paper are to now provide quantitative reusable product benefits on a U.S. national environmental and economic basis. This is the first quantitative, novel multi-user economic evaluation of selecting cleanroom reusables over disposables. For personal protection equipment (PPE), these cost and environmental-benefits indicate there is also an improved environmental and economic aspect to the increased national demand for reusables related to Covid-19, while easily achieving necessary cleaning with approved detergents. The current reusable cleanroom market (14.1 million packages) was estimated to be 60% nonsterile and 40% sterilized. The total market is about 50% reusable and 50% disposable. This research documents there is an annual cost reduction of about 58% when selecting reusables over disposables giving an economic savings to the U.